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Ministry of Health · South & Southeast Asia

Vietnam medical device regulatory resources

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177,249 classification outcome records11 free resources24/25 topics with records7 regulations trackedAug 2026 fees reviewed

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Structured regulatory requirements

Explore all 39 source-linked facts →

24 of 25 research dimensions currently covered · 16 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified
Competent authority
Department of Health Infrastructure and Medical Devices (Cục Hạ tầng và Thiết bị y tế, IMDA) under the Ministry of Health is the competent authority for medical devices; from 22/11/2025 Cir…
Procedures decentralized to IMDA
IMDA handles: new Class C/D circulation numbers (Art. 32/32a Decree 98 as amended), post issuance examination (para 3 4 Art. 32), batch suspension (para 3 Art. 34), batch recall (para 4 Art…
3 source-linked facts
Checked 2026-08-25
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D02

Legal basis & guidance

Verified
Decree 98 amendment chain
Decree 98/2021/NĐ CP is in force as amended by Decree 07/2023/NĐ CP, Decree 96/2023/NĐ CP and Decree 04/2025/NĐ CP (consolidated scan published on IMDA's official library).
Decree 98/2021 effective dates
Decree 98/2021/NĐ CP on medical device management was issued 08/11/2021 and took effect 01/01/2022.
3 source-linked facts
Checked 2026-08-25
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D03

Device definition & scope

Verified
Accessory definition
An accessory is a product designated by the device owner for a specific purpose together with a specific medical device, to enable or support that device's use for its intended purpose.
Product owner definition
'Product owner' (Chủ sở hữu thiết bị y tế) is the organization or individual that supplies the device under its own name/trade name and is responsible for design, manufacture, assembly, pro…
2 source-linked facts
Checked 2026-08-25
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D04

Classification rules

Verified
Risk classes A through D.
Class A, Class B, Class C, Class D
1 maintained scheme
Checked 2026-08-25
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D05

Registration pathways

Verified
Fast-track and urgent C/D channels
Dedicated application forms exist for fast track (cấp nhanh, Mẫu 06) and urgent (cấp khẩn cấp, Mẫu 07) Class C/D circulation number applications under Circular 44/2025.
Market-access routes by class
Class C/D devices may only circulate in Vietnam with a circulation number (số lưu hành) issued by the competent authority; Class A/B devices circulate after declaration of the applied stand…
2 source-linked facts
Checked 2026-08-25
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D06

Reliance & recognition

Verified
ASEAN CSDT dossier format adopted
Vietnam's MOH issued Decision 2426/QĐ BYT (15/05/2021) adopting ASEAN guidance for preparing the common technical dossier for medical devices: harmonized dossier format only; national revie…
China NMPA approval: reliance route
statement: Decree 98/2021/NĐ CP (consolidated text 08/VBHN BYT of 6 March 2026) names China's NMPA as one of the 'reference countries' (nước tham chiếu): a Class C/D device holding a Certif…
3 source-linked facts
Checked 2026-09-15
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D07

Economic-operator roles

Verified
Owner-authorization model
Regulatory acts (e.g., advertising disclosure) are performed by the circulation number owner or an organization holding its written authorization; a standard power of attorney form (Mẫu giấ…
1 source-linked fact
Checked 2026-08-25
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D08

Establishment, import & distribution

Verified
Import licence issuance
IMDA issues medical device import licences under Art. 48 of Decree 98 (as amended); the application uses form Mẫu 10 of Circular 44/2025.
Registration is basis for import
A Class C/D circulation number is the legal basis for verification registration, import, export and circulation of the device in Vietnam.
3 source-linked facts
Checked 2026-08-25
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D09

Dossier requirements

Verified
A/B declaration dossier article
The contents of the Class A/B declaration of applied standard dossier are specified in a dedicated article (Art. 24) of Decree 98.
Standard submission templates
Circular 44/2025 prescribes standard templates for the power of attorney (Phụ lục V), warranty capability certificate (Phụ lục VI), device technical documentation (Phụ lục VII) and export/i…
2 source-linked facts
Checked 2026-08-25
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D10

Official forms & portals

Verified
Current form taxonomy (Mẫu 01-16)
Current administrative forms are Mẫu 01 16 of Circular 44/2025: 01 production conditions declaration; 02/03 Class A/B standard application declaration; 04 08 Class C/D new applications (QCV…
1 source-linked fact
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
Electronic supply of IFU and warranty information (Art. 22(3))
Where the Vietnamese instructions for use and the warranty information do not accompany the device, they must be supplied in electronic form, and the device label must clearly show how to l…
Vietnamese instructions for use and complete label (Art. 22(1)(b)-(c))
A medical device may only circulate on the Vietnamese market if it has a label carrying the complete information required by the current goods labelling legislation and is supplied with ins…
3 source-linked facts
Checked 2026-09-07
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D12

QMS, audit & inspection

Verified
Production-conditions declaration
Domestic manufacturing establishments must make a declaration of adequate production conditions (công bố đủ điều kiện sản xuất) using form Mẫu 01, with updates to the declared dossier notif…
1 source-linked fact
Checked 2026-08-25
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D13

Standards, testing & ancillary approvals

Unresolved
Medical electrical evidence
Electrical safety
MOH medical device import licence
Import CoC / PVoC
MOST/MIC ICT conformity certification and declaration
Wireless / radio
7 maintained overlays
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Class A standards declaration
VND 500,000
Class B standards declaration
VND 1,500,000
3 maintained fee lines · 1 related fact
Checked 2026-08-25
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D15

Review clocks

Verified
Class A · Declaration of applied standards (provincial Department of Health)
0 days
Class B · Declaration of applied standards (provincial Department of Health)
0 days
Class C · Circulation number registration (Ministry of Health)
45 days
4 maintained pathways · 1 related fact
Checked 2026-08-29
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D16

Approval validity & renewal

Verified
Authorization duration
Class C/D circulation numbers are issued without expiry (indefinite, subject to ongoing compliance); import licences under the pre 2025 regime were extended only to 31/12/2024.
Continuation-request mechanism
For Class C/D devices, the owner submits a commitment and request for continued circulation (Phụ lục IV Mẫu 01) and IMDA issues a written continuation decision (Mẫu 02); these decisions are…
2 source-linked facts
Checked 2026-08-26
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Lifecycle & post-market

D17

Change control

Verified
Dossier-update notification outcomes
Dossier information changes are handled by notification on dedicated forms: Mẫu 12 (production conditions dossier), Mẫu 13 (Class A/B declaration dossier), Mẫu 14 (Class C/D registration do…
1 source-linked fact
Checked 2026-08-26
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D18

UDI, listing & traceability

Verified
Traceability is a statutory principle
Decree 98 makes traceability of medical devices (truy xuất nguồn gốc) one of the statutory management principles for devices.
1 source-linked fact
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
Clinical-trial approval regime
Clinical investigations of medical devices operate under an MOH approval regime: dossiers for approval and for amendments to approved trials (phê duyệt thay đổi thử nghiệm lâm sàng) are pre…
1 source-linked fact
Checked 2026-08-25
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D20

Special access & derogation

Verified
Emergency marketing numbers (Art. 29(3))
For medical devices serving epidemic prevention and control, natural disaster or catastrophe remediation in urgent cases on a list issued by the Ministry of Health, MOH grants a new emergen…
1 source-linked fact
Checked 2026-08-29
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D21

Manufacturer PMS

Verified
Export/import/inventory/use reporting template
A statutory reporting template exists for export, import, inventory and use of devices (and manufacturing materials/external check substances containing narcotics or precursors), directed t…
1 source-linked fact
Checked 2026-08-25
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D22

Vigilance & incident reporting

Verified
Incident handling duties (Arts. 34-35)
On a warning from a competent Vietnamese or international authority about a latent risk that seriously threatens public health or could cause death, the marketing number holder must inform…
1 source-linked fact
Checked 2026-08-29
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D23

Recall, FSCA & market surveillance

Verified
Batch suspension and recall powers
IMDA may suspend and terminate suspension of circulation of device batches (para 3 Art. 34) and order batch recalls (para 4 Art. 34) under Decree 98 as amended.
Specialized inspection scope
From Circular 44/2025, IMDA conducts specialized inspection (per para 1 Art. 6 Decree 217/2025/NĐ CP) over organizations performing classification, manufacture, circulation, trading, export…
2 source-linked facts
Checked 2026-08-25
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D24

Advertising, claims & promotion

Verified
Advertising disclosure regime (from 22/11/2025)
Device advertising operates via public disclosure (công khai) of intended advertising content and form using form Mẫu 16, filed by the circulation number owner or its written authorized org…
Legacy advertising confirmation regime
Circular 09/2015/TT BYT (25/05/2015) established the prior confirmation regime (xác nhận nội dung quảng cáo) for special products under MOH; current device advertising uses the disclosure m…
2 source-linked facts
Checked 2026-08-25
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D25

Submission communications & appeal

Verified
Dossier-resolution authority
Decree 98 designates the authority competent to resolve Class C/D registration dossiers in a dedicated article (Art. 30); since 22/11/2025 this authority is IMDA.
1 source-linked fact
Checked 2026-08-25
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Ministry of Health / IMDA registration fees in VND · reviewed 2026-08-25

Fee lineAmountProvenance
Class A standards declarationVND 500,000Verified
Class B standards declarationVND 1,500,000Verified
Class C/D circulation-number applicationVND 3,000,000Verified

Registration timeline

Full registration timeline →

Ministry of Health - Department of Medical Equipment and Health Works (Ministry of Health) review clocks and planning ranges · 4-class (A, B, C, D) classification

Class / pathwayReview clockPlanning totalProvenance
Class A(Declaration of applied standards (provincial Department of Health))0 days1-2 weeksVerified
Class B(Declaration of applied standards (provincial Department of Health))0 days1-2 weeksVerified
Class C(Circulation number registration (Ministry of Health))45 days4-5 monthsVerified
Class D(Circulation number registration (Ministry of Health))45 days4-5 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(0 days)
  5. 5Registration Approval(1-2 weeks)

Latest regulation news

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Newest official Ministry of Health headlines from the daily-refreshed feed — every row links directly to the authority publication.

Official Ministry of Health rules and guidance · 7 of 7 documents linked to official sources

Circular 05/2022/TT-BYTCircular 05/2022/TT-BYT - Classification Details (English)
ClassificationVerified
Circular 39/2016/TT-BYTCircular 39/2016/TT-BYT - Classification Rules (Superseded)
ClassificationVerified
Decree 04/2025/ND-CPNghị định 04/2025/NĐ-CP sửa đổi, bổ sung một số điều của Nghị định 98/2021/NĐ-CP
GeneralVerified
Decree 98/2021/ND-CPDecree 98/2021/ND-CP - Management of Medical Devices (English)
GeneralVerified

Computed from 177,249 official MOH classification outcome records · data as of 2026-08-31

New classification outcomes by year
2020202120222023202420252026
VerifiedMOH registry · as of 2026-08-31
159,783
Active classification outcomes
5,209
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